The following data is part of a premarket notification filed by Implex Corp. with the FDA for Nexgen Lps Trabecular Metal Monoblock Tibia; Zimmer Cat # 00-5886-xxyy, Implex Part # 05-121-xxyy-0.
| Device ID | K020295 |
| 510k Number | K020295 |
| Device Name: | NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-5886-XXYY, IMPLEX PART # 05-121-XXYY-0 |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | Les Heimann |
| Correspondent | Les Heimann IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-28 |
| Decision Date | 2002-02-12 |
| Summary: | summary |